Trial ChiCTR2000029658
Publication Wu CN, Br J Anaesth, 2020 (published paper)

Funding: Public/non profit (First Affiliated Hospital of Guangzhou University of Chinese)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / China
Follow-up duration (days): 7
Inclusion criteriaAdults (aged >18 yr), with clinically-confirmed COVID-19 pneumonia and hypoxaemia (defined as the ratio of arterial oxygen tension [PaO2] to inspiratory oxygen fraction [FIO2] <300 mm Hg), and requiring intubation in the ICU
Exclusion criteriaNR
Interventions
Treatment
HFNO (50L/m)Co-Intervention: GAnaes
Duration : 4 min
Control
Mask (15L/m)
Duration : 4 min
Participants
Randomized
60 participants (n1=30 / n2= 30)
Characteristics of participants
N=60
Mean age : 65.7
33 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=60
Primary outcome
In the register
the lowest SpO2 during intubation
In the report
Total intubation time
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

NR
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does not reflect the reported primary outcome. Some outcomes from the registry are not reported in the paper (e.g., mortality). Adverse events are not reported. Some outcomes (e.g.,mask ventilation for SpO2 <90%) are reported in the paper, but was not pre-specified in the trial registry/protocol. Of note: participants in the HFNO group received oxygen during intubation, while patients in standard mask oxygenation did not.